POS0684 IS UPADACITINIB CAPABLE OF IMPROVING PATIENT-REPORTED OUTCOMES OF RHEUMATOID ARTHRITIS IN A REAL-WORLD SETTING? RESULTS FROM THE POST-MARKETING OBSERVATIONAL UPwArds STUDY
Authors: T. Witte, U. Kiltz, F. Haas, E. Riechers, U. Prothmann, D. Adolf, C. Holland, A. Roessler, K. Famulla, K. Götz, K. Krueger
Journal: Annals of the Rheumatic Diseases (2022)

Background The efficacy of Upadacitinib (UPA), a selective Janus kinase inhibitor, has been evaluated in the SELECT clinical program 1-6 . In addition, recent results from the non-interventional UPwArds study further confirmed UPAs clinical effectiveness regarding standard disease activity scores for rheumatoid arthritis (RA) in a real-world setting 7 . However, patient-reported outcomes (PROs) as another cornerstone of clinical decision making yet remain to be addressed in the context of a post-marketing setting. This interim analysis, conducted after 250 patients had completed the 6-month follow-up visit, aims to fill this gap. Objectives To evaluate the change of selected PROs over 6 months in patients treated with UPA in a real-world data environment. Methods UPwArds is a prospective, open-label, multicenter, non-interventional, post-marketing study including adult patients with moderate-to-severe RA (swollen joint count [SJC28] ≥ 3 and inadequate response or intolerance to at least one previous disease-modifying antirheumatic drug). According to the German label, patients were treated with UPA 15 mg once daily, as monotherapy or in combination with methotrexate. For this analysis, the following PROs were included: 0-10 numerical rating scales (NRS) for pain and fatigue, the Health Assessment Questionnaire Disability Index (HAQ-DI), the duration and severity of morning stiffness, the Patient Health Questionnaire 9 (PHQ-9), and the Rheumatoid Arthritis Impact of Disease Questionnaire (RAID). Changes from baseline were evaluated for follow-up periods of 1 month, 3 months, and 6 months. Results are presented for the total sample using descriptive measures reflecting sample size (N), average values (standard deviation) for each assessment and average change scores (standard deviation) for follow-up visits. All data were analyzed as observed, with no imputation of missing data. Results 483 patients (369 female, 114 male) were included in the study, with available baseline PRO information for 481 patients. 6-months follow-up data were yet available from 279 patients The baseline average age and disease duration were 58.0 (12.3) years and 9.0 (8.0) years, respectively, whereas the mean initial DAS28-CRP was 4.6 (1.0). At baseline, 60.8% of enrolled patients had previously been treated with biologic or targeted synthetic disease-modifying antirheumatic drugs. Overall, PRO scores improved from baseline throughout month 6 with a considerable amelioration at month 3, which was maintained at month 6. Responses were rapid, with improvement already evident at month 1 (Table 1). The NRS pain as a crucial PRO in RA confirmed the previously described pattern of results seen for most of the other PROs (Figure 1). Table 1. Baseline scores and average changes from baseline scores N Baseline scores (SD) N Change from baseline - month 1 (SD) N Change from baseline - month 3 (SD) N Change from baseline - month 6(SD) Pain (NRS) 481 6.2 (2.2) 393 -2.2 (2.3) 392 -2.5 (2.5) 258 -2.4 (2.4) Fatigue (NRS) 481 5.5 (2.6) 393 -1.4 (2.3) 393 -1.6 (2.4) 259 -1.5 (2.3) HAQ-DI 471 1.3 (0.6) 380 -0.2 (0.3) 376 -0.2 (0.4) 253 -0.2 (0.4) Morning stiffness (duration, minutes) 439 68.9 (63.9) 313 -25.0 (55.3) 296 -29.6 (54.9) 179 -31.6 (51.7) Morning stiffness (severity) 478 5.2 (2.7) 386 -1.8 (2.3) 393 -2.2 (2.6) 258 -2.2 (2.9) PHQ-9 477 8.7 (5.2) 383 -1.9 (3.9) 381 -2.3 (4.0) 255 -2.2 (3.8) RAID 481 5.6 (2.0) 393 -1.7 (1.8) 392 -2.0 (2.0) 258 -1.9 (1.9) Conclusion This interim analysis confirmed a meaningful improvement regarding included PROs that cover various RA-related symptoms, depressiveness and the impact of symptoms of RA on daily life. References [1]Smolen JS, et al. Lancet 2019;393:2303–11 [2]Burmester GR, et al. Lancet 2018;391:2503–12 [3]Genovese MC, et al. Lancet 2018;391:2513–24 [4]van Vollenhoven R, et al. Arthritis Rheumatol 2020;72:1607–20 [5]Fleischmann R, et al. Arthritis Rheumatol 2019;71:1788–800 [6]Rubbert-Roth A, et al. N Engl J Med 2020;383:1511–21 [7]Witte T et al. P0833 at ACR, Nov 5–9, 2021 Acknowledgements AbbVie funded this study; contributed to its design; participated in data collection, analysis, and interpretation of the data; and in the writing, review, and approval of the abstract. AbbVie and the authors thank all study investigators for their contributions and the patients who participated in this study. No honoraria or payments were made for authorship. The medical writing support was provided by Matthias Englbrecht, Freelance Healthcare Data Scientist (Eckental, Germany) and was funded by AbbVie. Statistical analyses were provided by Dr. Daniela Adolf of StatConsult GmbH (Magdeburg, Germany) which was funded by AbbVie. Disclosure of Interests Torsten Witte Grant/research support from: AbbVie, Amgen, Bristol-Myers Squibb, Celgene, Chugai, Gilead, Janssen, Lilly, MSD, Mylan, Novartis, Pfizer, Roche, and UCB, Uta Kiltz Consultant of: AbbVie, Biocad, Eli Lilly and Company, Grünenthal, Hexal, Janssen, MSD, Novartis, Pfizer, Roche, and UCB, Grant/research support from: AbbVie, Amgen, Biogen, Fresenius, GSK, Hexal, Novartis, and Pfizer, Florian Haas Consultant of: AbbVie, Celgene, Novartis, and Pfizer, Grant/research support from: AbbVie, BMS, Celgene, Chugai, MSD, Novartis, Pfizer, Roche, and Sanofi Genzyme, Elke Riechers Consultant of: AbbVie, Chugai, Novartis, and UCB, Grant/research support from: AbbVie, Chugai, Lilly, Janssen, Novartis, Pfizer, Roche, and UCB, Ulrich Prothmann Grant/research support from: AbbVie, Amgen, Bristol-Myers Squibb, Chugai, Glaxo Smith Kline, Novartis, Pfizer, Roche, Sanofi, SOBI, and UCB, Daniela Adolf Shareholder of: Employee of StatConsult and may own stock or options, Employee of: Employee of StatConsult, Carsten Holland Shareholder of: Employee of AbbVie and may own stock or options, Employee of: Employee of AbbVie, Alexander Roessler Shareholder of: Employee of AbbVie and may own stock or options, Employee of: Employee of AbbVie, Kirsten Famulla Shareholder of: Employee of AbbVie and may own stock or options, Employee of: Employee of AbbVie, Konrad Götz Shareholder of: Employee of AbbVie and may own stock or options, Employee of: Employee of AbbVie, Klaus Krueger Grant/research support from: AbbVie, Biogen, BMS, Celltrion, Gilead, Hexal, Janssen, Lilly, Medac, MSD, Novartis, Pfizer, Roche, and UCB